capabilities
Everything we do is built around a patient-first mindset and delivering excellence. Adaptable platforms, focused management, modern infrastructure, and scalable manufacturing keep programs moving from development through commercial supply.
Adaptable platforms, focused program management, modern infrastructure, and scalable manufacturing keep programs moving from development through commercial supply.
Operations that adapt to a variety of injectable therapies.
Agile scale-up and tech transfers move with ease.
Hands-on project managers provide end-to-end oversight.
One-stop for effortless transitions from science to supply.
facilities
Infrastructure with integrity.
Our manufacturing infrastructure brings together the specialized environments, equipment, and operational resources required to support sterile injectable programs with flexibility, consistency, and control. Modern, U.S.-based facilities are designed to support sterile injectable development, clinical production, and commercial supply.
laboratory
Our on-site cGMP laboratory delivers analytical and microbiological testing that supports sterile injectable programs from formulation through final release.
fill-finish
Our flexible, cGMP-compliant fill-finish facility supports sterile injectable manufacturing with advanced controls, scalable systems, and reliable performance.
Packaging + warehouse
Through dedicated partnerships, we streamline product integrity, regulatory compliance, and supply chain continuity from final inspection through distribution.
equipment
Our advanced equipment platform combines automation, precision controls, and scalable systems to support reliable sterile injectable manufacturing.
faqs
Have questions about our capabilities? Explore key details on sterile manufacturing, development, analytical services, quality, facilities, and supply chain support, and see how we help programs progress from early development through commercial readiness.
connect today
Everything we do is shaped by our commitment to ensure life-changing injectables are manufactured with integrity and delivered with urgency to patients. Our unified model connects progressive science and dedicated service, creating a cohesive path from formulation to fill-finish.
American Injectables provides clinical and commercial sterile drug product manufacturing services, with capabilities supporting sterile injectable programs from development through commercial supply.
American Injectables operates from 15261 Telcom Dr, in Brooksville, Florida. Our FDA-approved facilities are purpose-built for sterile injectable manufacturing including fill-finish, labs, and package and warehousing.
American Injectables supports sterile injectable drug products, including vial and syringe formats across development, clinical, registration, and commercial stages.
Yes. American Injectables has dedicated analytical laboratory capabilities, supported by a team of scientists focused on formulation, analytical development, stability, and related activities.
American Injectables supports flexible manufacturing scales, including compounding up to 1,000L and vial batch sizes ranging from approximately 1,000 to 150,000 units.
Each project follows a structured lifecycle from business development through formulation and commercialization. Clients are supported by a dedicated project manager who serves as the primary point of contact.
Yes. Each customer project is assigned a project manager to coordinate communication, documentation, timelines, and project activities.
Project meetings are typically scheduled weekly or bi-weekly, depending on client preference and project needs.
Project documentation is organized through shared document systems, trackers, and meeting minutes. Documentation needs are planned early and reviewed with clients throughout the project.
Yes. Client review periods are built into project timelines to support alignment, feedback, and formal approval workflows.
Yes. American Injectables supports analytical development, method verification, method validation, and stability studies through its internal laboratory capabilities.
Available instrumentation includes HPLC/UPLC, GC, UV-Vis, Karl Fischer, osmometer, density meter, viscometer, FTIR, liquid particle counter, pH meter, CCIT equipment, moisture analyzer, and other analytical systems.
Yes. American Injectables supports stability studies with chambers for standard ICH conditions, as well as photostability capabilities.
American Injectables performs many common parenteral testing activities in-house, including CCIT, endotoxin, bioburden, and other analytical and microbiological testing. Specialized testing may be outsourced to qualified third-party laboratories.
Batch release testing timelines vary by program, but release testing that includes sterility is typically planned around a multi-week timeline.
American Injectables’ fully integrated Groninger vial filling line includes:
American Injectables’ fully integrated Optima syringe filling line includes:
Yes. American Injectables uses single-use systems where appropriate, including single-use bags and components for compounding and sterile holding applications.
American Injectables uses Pall Allegro mixing systems with single-use bags and supports compounding scales up to 1,000L.
American Injectables does not currently offer lyophilized formulation services.
Yes. American Injectables has oxygen control capabilities for both dissolved oxygen in solution and vial and syringe headspace management.
Yes. Manufacturing areas include switchable white and amber lighting to support products with light sensitivity requirements.
Yes. American Injectables operates under applicable cGMP requirements, including 21 CFR Parts 210, 211, and 820.
American Injectables maintains a Quality Management System designed to ensure manufacturing processes are performed in accordance with approved procedures, customer requirements, and regulatory standards.
Yes. American Injectables maintains processes for change control, quality events, deviations, CAPAs, batch record review, product disposition, and client notification in accordance with approved quality agreements.
Yes. Batch record review, product disposition, sampling, testing, and documentation review are managed through established quality processes.
Yes. BSE/TSE-free statements can be provided as part of finished drug product disposition documentation when applicable.
Yes. American Injectables maintains internal procedures for method transfer and technical transfer, aligned with applicable ICH guidance.
American Injectables’ facilities support production, stability, in-process operations, warehousing, quality control, microbiology, R&D, and analytical laboratory activities.
Production areas include controlled cleanroom environments ranging from ISO 8 access areas through ISO 5 filling, stoppering, and sealing zones.
American Injectables uses modern filling equipment, including vial filling and syringe/cartridge filling systems, supported by newer or recently installed process equipment.
Equipment validation follows a risk-based approach, including IQ, OQ, and PQ activities. Equipment is supported by calibration, preventive maintenance, and periodic requalification programs.
The site includes water and utility systems that support sterile manufacturing operations, including RODI feeding WFI and clean steam generation, process air, and nitrogen capabilities.
Yes. The facility is supported by backup power systems designed to reduce operational risk during power disruptions.
Yes. American Injectables has refrigerated storage, ambient controlled storage, and stability chamber capacity. Cryogenic storage is not currently offered.
American Injectables maintains a materials management program to support sourcing, handling, storage, shelf-life management, and regulatory compliance.
Yes. Supplier selection, qualification, and ongoing evaluation are managed through a supplier management program designed to support quality, compliance, and supply reliability.
Yes. American Injectables has vendor qualification and approval processes for raw material vendors and other suppliers.
Yes. Supplier and customer change notification processes are in place to support transparency and quality alignment.
Where appropriate, American Injectables can evaluate dual sourcing strategies for high-risk materials, APIs, excipients, and packaging components.
Yes. American Injectables uses an inventory management system to support materials tracking and control.
Labeling and packaging capabilities are part of American Injectables’ planned service expansion, with third-party vendor support available where appropriate.
Serialization capabilities are part of American Injectables planned service expansion, with third-party vendor support available where appropriate.
Yes. American Injectables maintains a business continuity plan that can be reviewed as part of client due diligence.
American Injectables maintains risk management processes, backup power support, supplier controls, and project planning practices to help reduce disruption and support continuity.
Yes. American Injectables can provide standard agreement templates and is open to reviewing sponsor-provided templates when appropriate.
